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STOCK RECAP #PipelineProspector

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Pipeline Prospector Feb 2025: Bain buys Mitsubishi Tanabe for US$ 3.4 bn; Japan’s Ono gets FDA nod for rare joint tumor drug
February was a mixed bag for biopharma indices, underscoring the volatility and uncertainty in the sector. The Nasdaq Biotechnology Index (NBI) managed a modest gain of 1.16 percent, climbing from 4,466.41 to 4,518.06. However, the SPDR S&P Biotech ETF (XBI) fell 2.06 percent from 90.58 to 88.71, and the S&P Biotechnology Select Industry Index (SPSIBI) experienced a more substantial drop of 4.26 percent, declining from 7,222.3 to 6,914.8.The month saw several notable developments among Asian pharmaceutical companies, signaling their growing influence. Meanwhile, the confirmation of Robert F. Kennedy Jr. as the US Secretary of Health and Human Services (HHS) cast a veil of uncertainty over the sector, prompting investors to brace for potential shifts in vaccine policy and regulatory oversight. Access the Pipeline Prospector Dashboard for February 2025 Newsmakers (Free Excel)Bain buys Mitsubishi Tanabe in US$ 3.4 bn deal; Japan’s Ono secures FDA nod for joint tumor drugUS private equity firm Bain Capital acquired Mitsubishi Tanabe Pharma for approximately JPY 510 billion (US$ 3.4 billion). This strategic acquisition positions Bain to leverage the Osaka-based pharmaceutical company’s expertise in central nervous system disorders, immuno-inflammation, and oncology.Bain’s investment reflects growing confidence in Japan’s life sciences sector, particularly in light of the recent initiatives by the Japanese government to accelerate the development and approval of innovative medicines. Japan’s Ono Pharmaceutical (stock up 2 percent) received FDA approval for Romvimza (vimseltinib), a treatment for tenosynovial giant cell tumor (TGCT), a rare condition affecting joints. The approval follows Ono’s US$ 2.4 billion acquisition of Deciphera Pharmaceuticals, which included Romvimza and other cancer drugs. Romvimza will compete with Daiichi Sankyo’s Turalio (pexidartinib), the only other FDA-approved systemic treatment for TGCT.Meanwhile, Radiance Biopharma has acquired an antibody-drug conjugate (ADC) asset from China’s CSPC Megalith Biopharmaceutical. The ADC targets ROR1 (receptor tyrosine kinase-like orphan receptor 1), a protein implicated in embryonic development and cancer pathways. The transaction structure includes an upfront payment of US$ 15 million, with potential milestone payments exceeding US$ 1 billion.Continuing with its aggressive dealmaking, Novartis agreed to acquire Anthos Therapeutics, an anticoagulant drug development company majority-owned by investment firm Blackstone, for up to US$ 3.1 billion, with US$ 925 million paid upfront. Anthos emerged from a partnership between Blackstone and Novartis to develop abelacimab, a novel blood-thinning drug aimed at preventing strokes and dangerous blood clots in patients with atrial fibrillation. Access the Pipeline Prospector Dashboard for February 2025 Newsmakers (Free Excel) FDA okays SpringWorks’ med for rare genetic condition, AbbVie-Pfizer’s antibiotic for drug-resistant infectionsFDA approved SpringWorks Therapeutics’ Gomekli (mirdametinib) for the treatment of neurofibromatosis type 1 (NF1), a rare genetic condition that causes tumors to grow along nerve tissues throughout the body, often resulting in severe pain and physical deformity. Gomekli is the first and only medicine approved for addressing this condition in both pediatric and adult populations with inoperable tumors. SpringWorks’ shares skyrocketed 57 percent in February. Meanwhile, reports suggest that Germany’s Merck KGaA is currently in advanced talks to acquire Connecticut-based SpringWorks.AbbVie and Pfizer received FDA approval for Emblaveo (aztreonam and avibactam), a novel intravenous antibiotic developed jointly for the treatment of complicated intra-abdominal infections (cIAIs) in adults with limited or no alternative treatment options. To be used in combination with metronidazole, Emblaveo targets gram-negative bacteria, including drug-resistant strains.AbbVie (stock up 9 percent) further strengthened its oncology portfolio with a collaboration with Xilio Therapeutics to develop novel tumor-activated immunotherapies, including masked T-cell engagers. This partnership could potentially be worth over US$ 2 billion.Mirum Pharma’s Ctexli (chenodiol) was approved as the first targeted treatment for cerebrotendinous xanthomatosis (CTX), a rare lipid storage disease.In drug-device combinations, Supernus Pharmaceuticals received FDA approval for Onapgo, a treatment of motor fluctuations in adults with advanced Parkinson’s disease. Onapgo is a wearable device that continuously delivers apomorphine hydrochloride subcutaneously throughout waking hours.Meanwhile, Roche’s Susvimo (ranibizumab injection) eye implant received a label expansion to include the treatment of diabetic macular edema (DME). Additionally, Roche (stock up 8 percent) reported promising late-stage clinical data for its blood cancer drug Gazyva (obinutuzumab) in lupus nephritis. Access the Pipeline Prospector Dashboard for February 2025 Newsmakers (Free Excel) RFK Jr’s confirmation as HHS Secy hits vaccine makers; GSK gains on buyback plan; FDA okays 5-strain meningitis vaccineWith RFK Jr taking charge of HHS, stocks of vaccine makers took a hit. For instance, Bavarian Nordic’s stock fell by 11 percent, even though its chikungunya vaccine Vimkunya got approved by the FDA on February 14.Meanwhile, FDA paused a late-stage trial of Moderna’s experimental norovirus vaccine, mRNA-1403. The pause came after a single reported case of Guillain–Barré syndrome — a rare neurological side effect. Moderna’s stock fell 21 percent.In contrast, GSK’s stock rose 9 percent after it launched a £ 2 billion (US$ 2.5 billion) share buyback and raised its long-term sales target to nearly US$ 50 billion by 2031, largely driven by robust growth in specialty medicines, such as its HIV and cancer treatments. The British pharma giant also received FDA approval for its meningitis combination vaccine, Penmenvy. This five-in-one vaccine protects against five strains of Neisseria meningitidis, combining protective components of two existing vaccines into a single shot. Sanofi (stock up 2 percent) announced plans to repurchase € 5 billion (US$ 5.21 billion) worth of its shares in 2025 following the anticipated sale of its Opella consumer healthcare unit to private equity firm Clayton, Dubilier & Rice for € 15.5 billion (US$ 16.11 billion). The French giant also indicated it could be “a bit more” active with mergers and acquisitions in the near future. As part of Sanofi’s share buyback program, L’Oréal has agreed to sell a € 3 billion (US$ 3.11 billion) stake in Sanofi back to the drugmaker.The month saw some dramatic exits in the gene therapy space. Bluebird Bio, which was once valued at about US$ 10 billion, agreed to be acquired by private equity firms Carlyle and SK Capital Partners for less than US$ 30 million. Similarly, Pfizer announced it would discontinue the global development and commercialization of its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt), which is priced at US$ 3.5 million per treatment. Access the Pipeline Prospector Dashboard for February 2025 Newsmakers (Free Excel) Our view The biopharma sector is doing the right things by taking strategic business decisions, focusing on innovation and a strong drug pipeline. However, the geopolitical environment is uncertain. With a trade war ensuing between the US, China, Mexico and Canada, and the Trump administration suspending all military aid to Ukraine, we are entering uncertain times when it's difficult to say what the next few months would look like for the biopharma sector.

Impressions: 3279

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2025-bain-buys-mitsubishi-tanabe-for-us-3-4-bn-japan-s-ono-gets-fda-nod-for-rare-joint-tumor-drug

#PharmaFlow by PHARMACOMPASS
06 Mar 2025

WEEKLY NEWS RECAP #Phispers

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FDA okays Vertex’s non-opioid painkiller, Supernus’ wearable device for Parkinson’s; Sanofi, GSK plan share buybacks
While the healthcare sector in the US was embroiled in political uncertainties over tariffs and key appointments, the country’s Food and Drug Administration (FDA) focused on approving new classes of drugs and drug-device combinations.Vertex Pharmaceuticals made headlines with the FDA approval of Journavx, a groundbreaking non-opioid painkiller that offers a safer alternative to traditional opioids. After setbacks, Axsome Therapeutics’ dual-action migraine treatment, Symbravo, finally received an FDA approval.In the realm of Parkinson’s disease treatment, Supernus Pharmaceuticals received FDA approval for Onapgo, a wearable drug-device combination designed to improve motor control. Roche also expanded the use of its Susvimo eye implant to treat diabetic macular edema, offering a continuous delivery system that reduces treatment burden.Meanwhile, Sanofi announced a US$ 5.21 billion share buyback program following the announcement of the € 15.5 billion (US$ 16.1 billion) sale of its consumer healthcare unit, Opella, likely to go through in the second quarter of 2025. GSK also launched a US$ 2.5 billion share buyback and raised its long-term sales target to nearly US$ 50 billion by 2031.AbbVie, on the other hand, appears to have smoothly navigated the decline in Humira sales, raising its long-term outlook for its immunology duo, Skyrizi and Rinvoq, with combined sales projected to exceed US$ 31 billion by 2027. However, Merck announced a halt in Gardasil vaccine shipments to China amid weak demand, impacting its financial guidance and long-term sales targets. And Alvogen issued a nationwide recall for some of its fentanyl patches due to a packaging defect that poses a major overdose risk.FDA approves Vertex’s non-opioid painkiller that blocks pain at sourceFDA has approved Vertex Pharmaceuticals’ non-opioid painkiller, Journavx (suzetrigine), for the treatment of moderate-to-severe acute pain in adults. This approval marks the first new class of pain medication in over two decades offering an alternative to opioid analgesics. Journavx functions by blocking pain signals at their source before they reach the brain. It works without affecting the brain’s reward centers. This mechanism reduces the risk of addiction associated with traditional opioids. Analysts estimate that the drug could generate approximately US$ 3.7 billion in US sales by 2030.Axsome’s migraine treatment okayed: Axsome Therapeutics has finally received FDA’s greenlight for its migraine treatment, Symbravo. This multi‐mechanistic medication combines meloxicam and rizatriptan with the aim to provide rapid pain relief and sustained efficacy by targeting multiple migraine pathways. Clinical studies demonstrated that a single oral dose of the novel drug helped patients return to normal functioning within two hours. It was a hard-fought win for Axsome after the agency declined to approve the drug in 2022 over issues regarding quality control processes that were unresolved.Sanofi signals M&A push, plans US$ 5.21 bn share buyback after US$ 16.11 bn sale of OpellaSanofi plans to repurchase € 5 billion (US$ 5.21 billion) worth of its shares in 2025, following the anticipated sale of its Opella consumer healthcare unit to private equity firm Clayton, Dubilier & Rice (CD&R) for € 15.5 billion (US$ 16.11 billion). The move signals a strategic shift towards focusing on innovative medicines and vaccines. Sanofi will retain a 50 percent stake in Opella, with plans to divest this holding in the future. The French giant also indicated it could be “a bit more” active with mergers and acquisitions in the near future. As part of Sanofi’s share buyback program, L’Oréal has agreed to sell a € 3 billion (US$ 3.11 billion) stake in Sanofi back to the drugmaker.GSK launches US$ 2.5 bn share buyback: GSK has launched a £ 2 billion (US$ 2.5 billion) share buyback and raised its long-term sales target to nearly US$ 50 billion by 2031, largely driven by robust growth in its specialty medicines such as HIV and cancer treatments. Despite vaccine sales falling in 2024 by 4 percent due to Arexvy losing 51 percent in sales, the British drugmaker’s oncology section saw a 98 percent increase in sales. Its antibody-drug conjugate (ADC) portfolio will be key, the company said, highlighting its recent IDRx acquisition and the launch of its multiple myeloma drug Blenrep (belantamab mafodotin).FDA approves Supernus’ wearable drug‐device combination for Parkinson’s diseaseSupernus Pharmaceuticals has received FDA approval for its drug‐device combination, Onapgo, for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. This marks the culmination of a years‐long effort after previous rejections in 2022 and 2024 due to concerns over product quality. Onapgo is a wearable device that continuously delivers apomorphine hydrochloride under the skin throughout the waking day.Roche’s Susvimo expanded to treat diabetic macular edema: Roche has gained FDA approval for a label expansion of its Susvimo eye implant to include the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. This approval builds on the implant’s initial indication for treating neovascular (wet) age-related macular degeneration (nAMD). Susvimo (ranibizumab injection) is the first and only continuous delivery treatment approved by the FDA for DME.AbbVie raises sales outlook for Skyrizi, Rinvoq; Merck halts Gardasil shipments to ChinaAbbVie has raised its long-term outlook by US$ 4 billion for its two leading immunology drugs, Skyrizi (risankizumab) and Rinvoq (upadacitinib), now forecasting their combined 2027 sales to exceed US$ 31 billion. The updated projection expects Skyrizi to generate more than US$ 20 billion in revenue, while Rinvoq is anticipated to contribute over US$ 11 billion by 2027. Skyrizi currently holds 40 percent of the total prescription share of the biologics psoriasis market, the company noted.Gardasil shipments to China: Merck announced it would halt shipments of its flagship Gardasil vaccine to China at least until mid-year. This decision comes amid economic challenges, weak demand and an anti-corruption campaign led by the government in China. The move has directly impacted Merck’s guidance for the full year 2025. Gardasil, the vaccine designed to prevent cancers caused by human papillomavirus (HPV), has experienced declining sales in China.Alvogen recalls fentanyl patches after report of serious adverse eventAlvogen has issued a voluntary nationwide recall for one lot of its fentanyl transdermal system 25 mcg/h patches due to a potential packaging defect. According to the FDA recall notice, the defect involves the risk that patches could be inadvertently stacked (i.e. multi-stacked) within a single product pouch. This stacking error could result in a significantly higher dose than intended, thereby posing a risk of serious, life-threatening, or even fatal respiratory depression. 

Impressions: 922

https://www.pharmacompass.com/radio-compass-phisper/fda-okays-vertex-s-non-opioid-painkiller-supernus-wearable-device-for-parkinson-s-sanofi-gsk-plan-share-buybacks

#Phispers by PHARMACOMPASS
06 Feb 2025

NEWS #PharmaBuzz

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https://pharma.economictimes.indiatimes.com/tag/apomorphine+hydrochloride

ECONOMICTIMES
01 Apr 2026

https://www.pharmiweb.com/press-release/2026-01-07/bial-launches-kynmobi-apomorphine-hydrochloride-in-the-united-kingdom-1

PHARMIWEB
07 Jan 2026

https://www.globenewswire.com/news-release/2025/08/25/3138861/0/en/Serina-Therapeutics-Announces-FDA-Feedback-Supports-Registrational-Trial-Design-of-SER-252-in-Advanced-Parkinson-s-Disease-under-505-b-2-NDA-Pathway.html

GLOBENEWSWIRE
25 Aug 2025

https://www.orionpharma.com/newsroom/all-news/releases/press-releases/2025/orion-and-criceto-announce-a-license-agreement-for-aporon-an-innovative-apomorphine-spray-to-treat-off-episodes-in-parkinsons-disease/

PRESS RELEASE
26 Apr 2025

https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine

PRESS RELEASE
05 Feb 2025

https://www.globenewswire.com/news-release/2024/08/06/2925489/19871/en/Supernus-Announces-Second-Quarter-2024-Financial-Results.html

GLOBENEWSWIRE
06 Aug 2024