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By PharmaCompass
2025-03-06
Impressions: 289
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 drug
US 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 infections
FDA 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 vaccine
With 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.
Pharma & Biotech Newsmakers in February 2025
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