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Biogen’s 2nd Alzheimer’s Antibody, BeiGene’s Cancer Drug Label Expansion, Adcom Test For Regeneron And More: January PDUFA Catalysts For Biotech Investors – iShares Biotechnology ETF (NASDAQ:IBB), SPDR Series Trust SPDR S&P Biotech ETF (ARCA:XBI)



Biopharma shares weren’t proof against the broader market downturn seen for a lot of 2022. The iShares Biotechnology ETF IBB, which is closely weighted with large-cap biotech firms, has misplaced 13.2% in comparison with a steeper 27.8% pullback by the SPDR S&P Biotech XBI.

What Occurred: This clearly means that the sell-off is extra acute within the small-cap house. More importantly, the declines of the 12 months got here on prime of sharp losses skilled by the sector in 2021.

See Additionally: Finest Biotech Socks Proper Now

The 12 months was a forgettable one from the basic perspective too. Drug innovation dwindled, as evident from the drop in new molecular entity approvals from 50 in 2021 to 34 in 2022. The alleviation of the COVID-19 state of affairs didn’t bode properly for vaccine producers and their shares pulled again in step with the lowered forecast for vaccine gross sales.

December proved to be a blended month for FDA approvals. Mirati Therapeutics Inc.’s MRTX adagrasib, a KRAS G12C inhibitor, obtained the nod for treating a sure sort of lung most cancers. Gilead Sciences Inc. GILD additionally succeeded in pushing its long-acting AIDS drug previous the end line.

On the flip aspect, Coherus Biosciences Inc.’s CHRS toripalimab approval has been delayed and Cytokinetics Inc. CYTK was hit by a damaging FDA panel verdict with respect to its coronary heart failure drug.

Listed below are the key PDUFA dates for the upcoming month:

Will MediWound’s Burn Therapy Emerge Unscathed On Second Strive?

Firm: MediWound Ltd. MDWD/Vericel Corp. VCEL

Sort of Utility: biologic license utility

Candidate: NexoBrid

Indication: thermal burns

Date: Jan. 1

Israel-based biotech MediWound’s NexoBrid resubmission was accepted for evaluate in early August for eschar elimination in adults with deep partial-thickness and/or full-thickness thermal burns. The corporate had out-licensed the North American industrial rights for the investigational remedy completely to Vericel.

MediWound’s authentic utility was handed down an entire response letter in late-June 2021, citing points with chemistry, manufacturing and controls.

NexoBrid, a focus of proteolytic enzymes enriched in Bromelain, is a topically administered organic product that enzymatically removes non-viable burn tissue, or eschar, in sufferers with deep partial and full-thickness thermal burns inside 4 hours of utility with out harming viable tissue.

NexoBrid is authorised within the European Union and different worldwide markets.

Biogen’s Second AD Remedy Awaits FDA Clearance

Firm: Biogen Inc. BIIB/Eisai Co. Ltd. ESALY

Sort of Utility: BLA

Candidate: lecanemab

Indication: gentle Alzheimer’s illness

Date: Jan. 6

Lecanemab is Biogen/Eisai’s investigational anti-amyloid beta protofibril antibody being evaluated for gentle cognitive impairment as a consequence of Alzheimer’s illness and gentle Alzheimer’s illness. This investigational asset assumes significance due to an absence of success with the combo’s first-approved Alzheimer’s therapy Aduhelm.

A draft report launched by the Institute for Scientific and Financial Evaluation confirmed that the therapy candidate will doubtless be priced between $8,500 and $20,600 yearly, making it cheaper than its predecessor remedy Aduhelm.

Detailed information launched from a late-stage research of lecanemab in late November confirmed that it succeeded in slowing cognitive decline however would possibly carry the chance of unwanted side effects for sure sufferers. Two deaths have been reported in a trial extension research.

Can Phathom’s Vonoprazan Snag Nod For A Second Indication?

Firm: Phathom Prescription drugs, Inc. PHAT

Sort of Utility: NDA

Candidate: vonoprazan

Indication: esophagitis and heartburn

Date: Jan.11

Phathom’s vonoprazan utility was accepted for evaluate in late-Might 2022 as a therapy choice for adults for the therapeutic of erosive esophagitis (EE), or irritation of the esophagus, and aid of heartburn, in addition to upkeep of therapeutic of EE and heartburn aid.

Vonoprazan is an orally administered investigational potassium-competitive acid blocker. It was authorised for treating Helicobacter pylori an infection in Might.

EE, in keeping with Phathom, is a significant sort of gastroesophageal illness affecting about 20 million folks within the U.S. If not adequately handled, EE might progress to most cancers.

Seagan Knocks FDA Door For Colorectal Cancer Drug Nod

Firm: Seagen Inc. SGEN

Sort of Utility: supplemental NDA

Candidate: Tukysa together with trastuzumab

Indication: colorectal most cancers

Date: Jan.19

The Tukysa-trastuzumab combo remedy is being evaluated for grownup sufferers with HER2-positive colorectal most cancers, who’ve obtained at the least one prior therapy routine. The applying was made based mostly on the outcomes of a Section 2 research dubbed MOUNTAINEER. There are not any presently no-FDA authorised therapies for metastatic colorectal most cancers that particularly goal HER2.

BeiGene Seeks Label Expansion For Blood Cancer Drug

Firm: BeiGene Ltd. BGNE

Sort of Utility: sNDA

Candidate: Brukinsa

Indication: blood most cancers

Date: Jan.20

BeiGene’s Brukinsa is presently beneath evaluate for continual lymphocytic leukemia and small lymphocytic lymphoma. By the way, the corporate communicated a three-month extension to the evaluate interval in mid-June, citing the extra time FDA required to evaluate the applying for increasing the Brukinsa label, following which a brand new PDUFA date was issued.

Brukinsa is a small-molecule compound found by BeiGene and is presently being evaluated globally in medical applications, as monotherapy and together with different therapies, to deal with B-cell malignancies. It has presently been authorised for treating mantle cell lymphoma and relapsed marginal zone lymphoma. It fetched revenues of $155.5 million within the third quarter, a 136% year-over-year development.

Merck’s Surprise Cancer Drug On Observe For One other Approval?

Firm: Merck & Co, Inc. MRK

Sort of Utility: sBLA

Candidate: Keytruda

Indication: lung most cancers

Date: Jan.29

Merck’s regulatory utility for Keytruda as an adjuvant therapy of sufferers with stage 1b, 2 or 3a non-small cell lung most cancers following full surgical resection was accepted for evaluate in mid-June 2022.

The applying was supported by information from the Section 3 KEYNOTE-091 trial, which demonstrated a major enchancment in disease-free survival for sufferers no matter PD-L-1 expression. Nonetheless, one other co-primary endpoint of disease-free survival in sufferers whose tumors categorical PD-L1 didn’t attain statistical significance.

Adcom Conferences

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee is scheduled to fulfill on Jan. 9 to debate Regeneron Prescription drugs Inc.’s REGN sBLA for aflibercept answer for intravitreal injection. The complement was submitted in response to FDA’s pediatric written request for research of aflibercept within the therapy of retinopathy of prematurity.

The Antimicrobial Drug Advisory Committee of the FDA will talk about on Jan. 24 Cidara Therapeutics Inc.’s CDTX NDA for rezafungin lyophilized powder for injection for the therapy of candidemia and invasive candidiasis in adults.

Learn Subsequent: 5 Most cost-effective Shares In The Healthcare Sector: Bio-Techne, Mirati Therapeutics And More

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