Food and Drug Administration decisions and advisory committee verdicts slated for November were mostly positive. New molecular entity approvals so far this year trail 2021’s tally by about 35%.
The two NMEs that were okayed in November include Provention Bio, Inc.’s PRVB Tzield, approved for delaying the onset of stage-3, type-1 diabetes, and ImmunoGen Inc.’s IMGN mirvetuximab soravtansine monotherapy – a treatment for recurrent ovarian cancer resistant to platinum therapy.
On the flip side, Spectrum Pharmaceuticals, Inc. SPPI received a complete response letter for its lung cancer drug application, prompting the company to pull the plug on the program.
The iShares Biotechnology ETF IBB, an exchange-traded fund tracking mostly large-cap biotechs, is down about 10% year-to-date, reflecting the travails faced by the sector.
Benzinga has previewed December’s Prescription Drug User Fee Act dates — deadlines fixed by the FDA to communicate its decision about the approval or non-approval of a drug.
It is a binary catalyst that can trigger big swings in stocks.
Can Mirati Get The Nod To Play Catch-Up To Amgen?
Company: Mirati Therapeutics Inc. MRTX
Type of Application: New drug application
Indication: lung cancer
Date: Dec. 14
Mirati’s adagrasib NDA was accepted for review in mid-February as a treatment option for patients with non-small cell lung cancer harboring KRAS G12C mutation, who have received at least one prior systemic therapy. If approved, adagrasib will be pitched against Amgen Inc.’s AMGN Lumakras – also a KRAS G12C inhibitor that was approved by the FDA in May 2021.
Lumakras fetched Amgen $214 million in revenue for the first three quarters of 2022.
Adagrasib’s uptake will largely hinge on the differences in its labeling vis-à-vis Amgen’s. Mirati currently has an out-licensing partnership with Chinese biotech Zai Labs Limited ZLAB for marketing the investigational drug in Greater China. FDA's decision on the drug, therefore, will likely have an impact on Zai Lab’s stock too.
Can 2nd Time Be Charm For Coherus?
Company: Coherus Biosciences, Inc. CHRS
Type of Application: biologic license application
Indication: nasopharyngeal carcinoma
Date: Dec. 23
Coherus and Chinese partner Shanghai Junshi Biosciences faced a rejection in May when the FDA issued a complete response letter for its toripalimab BLA. Toripalimab has been evaluated in combination with chemotherapy medications gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma.
It is also being studied as a monotherapy in second-line or later treatment of recurrent nasopharyngeal carcinoma after platinum-containing chemotherapy.
As the complete response letter sought only a quality process change, the companies resubmitted the BLA shortly after. The FDA accepted the resubmitted application in early July.
”Go” or No-Go” For Gilead’s Long-Acting AIDS Drug On Second Try?
Company: Gilead Sciences, Inc. (NASDAQ: GILD_
Type of Application: NDA
Indication: HIV-1 infection
Date: Dec. 27
Gilead’s lenacapavir is a long-acting HIV-1 capsid inhibitor for the treatment of HIV-1 infection in heavily treated people with multi-drug resistant HIV-1 infection. The original regulatory application was shot down with a complete response letter in March due to concerns over chemistry, manufacturing and controls issues.
The company’s resubmission was accepted for review in late July.
In late August, the European Commission approved the drug with the brand name Sunlenca. The company touts lenacapavir as a new, every-six-month treatment option that can be apt for HIV patients whose virus no longer effectively responds to their current therapy.
TG Therapeutics MS Therapy Awaits FDA Nod
Company: TG Therapeutics, Inc. TGTX
Type of Application: BLA
Indication: relapsing multiple sclerosis
Date: Dec. 28
TG Therapeutics’ublituximab review period was extended by three months in May, with the new PDUFA date set for Dec. 28. Ublituximab is an investigational monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. It is being evaluated for relapsing multiple sclerosis, a chronic disease of the central nervous system.
If approved, ublituximab will be up against Roche Holding AG’s RHHBY Ocrevus and Novartis AG’s NVS Kesimpta.
FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet on Dec. 13 to discuss Cytokinetics, Inc.’s CYTK NDA for omecamtiv mecarbil tablets. This investigational drug is being evaluated for reducing the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction.
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