The Week Ahead In Biotech (Nov. 21-Nov. 27): Takeda, Aadi, Fennec FDA Decisions, Earnings In The Spotlight In Holiday-Shortened Week

Biotech stocks showed a lack of direction in the week ending Nov. 19 before finishing modestly higher. Stocks did not have much meaningful catalysts to react to amid the winding down of the reporting season and ahead of the holiday week.

Among the major news of the week was Pfizer, Inc. PFE filing an application for emergency use authorization for its oral COVID-19 pill Paxlovid. The company also bagged a $5.29 billion contract from the U.S. government to supply the investigational antiviral treatment and announced a voluntary license agreement with a U.N.-backed body to facilitate greater access to the global population.

Biogen, Inc. BIIB was also in the news due to long-time company veteran and R&D head Alfred Sandrock, who oversaw the development of many breakthrough neurological treatments, announcing his retirement.

Connect Biopharma Holdings Limited CNTB came under intense selling pressure after what seemed like positive topline data from the Phase 2 study of its investigational therapy CBP-201 in atopic dermatitis. Lack of efficacy details from each arm of the study irked investors, as they could not weigh in vis-à-vis existing treatments.

On the other hand, Longeveron Inc. LGVN shares nearly doubled during the week after its Lomecel-B for hypoplastic left heart syndrome drug received a rare pediatric disease designation from the Food and Drug Administration.

Here are the key catalysts that can move stocks in the sector in the unfolding week:

Conferences

The 14th International Congress of Inborn Errors of Metabolism, or ICIEM, 2021 Meeting: Nov 21 - 24, to be held at Hilton Sydney, Sydney, New South Wales, Australia and also virtually

The Piper Sandler 33rd Annual Virtual Healthcare Conference: Prerecorded fireside chat will be made available from the week of Nov. 22, although the conference is scheduled between Nov. 30 and Dec. 2

PDUFA Dates

The FDA is scheduled to rule on Takeda Pharmaceutical Company Limited's TAK new drug application for maribavir (TAK-620), which is being evaluated for the treatment of refractory cytomegalovirus infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients. The PDUFA date is set for Tuesday, Nov. 23.

Aadi Bioscience, Inc. AADI has a tryst with the FDA on Friday, Nov. 26 regarding its NDA for Fyarro. Fyarro is Aadi's lead product that is being evaluated for PEComa, which are rare tumors that form in the soft tissues of the stomach, intestines, lungs, female reproductive organs, and genitourinary organs.

The drug regulator will rule, by the PDUFA date of Nov. 27, on Fennec Pharmaceuticals Inc.'s FENC NDA for Pedmark. Pedmark is a unique formulation of sodium thiosulfate, and is being evaluated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.

Related Link: Can Moderna Deliver A Highly Effective Flu Vaccine?

Clinical Readouts/Presentations

ICIEM Meeting Presentations

• Synlogic, Inc. SYBX: Additional Phase 2 data for bacterial therapeutic candidate SYNB1618 in patients with phenylketonuria (Tuesday, at 7:45 pm – 8:45 pm)
• Abeona Therapeutics Inc. ABEO: interim results of Transpher A, a multicenter, single-dose, phase 1/2 clinical trial of ABO-102 gene therapy for Sanfilippo syndrome type A (mucopolysaccharidosis IIIA) (Tuesday)
• Applied Therapeutics, Inc. APLT: new data on burden of illness for AT-007 in adults with galactosemia (Tuesday)

Earnings

• Twist Bioscience Corporation TWST (Monday, before the market open)
• Adamis Pharmaceuticals Corporation ADMP (Monday, after the close)
• Arrowhead Pharmaceuticals, Inc. ARWR (Monday, after the close)
• Enanta Pharmaceuticals, Inc. ENTA (Monday, after the close)
• Medtronic plc MDT (Tuesday, before the market open)
• Centogene N.V. CNTG (Wednesday, before the market open)
• Anavex Life Sciences Corp. AVXL (Wednesday, after the close)

IPO Quiet Period Expiry

• Entrada Therapeutics, Inc. TRDA
• Biofrontera Inc. BFRI
• Aura Biosciences, Inc. AURA
• LianBio LIAN

Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates