The Week Ahead In Biotech (Sept. 19-25): Incyte, Verrica FDA Decisions And Conference Presentations In The Spotlight

Biotech stocks declined for the week ending Sept. 17, extending the losses from the previous week. European Society for Medical Oncology presentations, vaccine news, clinical readouts and IPOs were among the catalysts for the week.

The week started off on a weak note for COVID-19 vaccine stocks after a scientific review published in the Lancet suggested that booster doses of vaccines may not be warranted at this point in time. An FDA Advisory Committee that met Friday voted against recommending Pfizer, Inc. (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX)'s third COVID-19 booster shot for the general population.

On the regulatory front, the Food and Drug Administration gave its nod of approval for Takeda Pharmaceuticals Company Ltd. (NYSE:TAK)'s Exkivity for the treatment of very rare lung cancer. On the other hand, the review period for Calliditas Therapeutics AB (NASDAQ:CALT)'s Nefecon as a treatment option for primary IgA Nephropathy was extended by three months.

Four healthcare stocks debuted following their IPOs, raising a combined $564.7 million in gross proceeds.

Here are the key catalysts for the unfolding week:

Conferences

European Society for Medical Oncology, or ESMO, 2021 Congress: Sept. 16-21
International Workshop On CLL, or iwCLL: Sept. 17-20
The Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: Sept. 20-23
World Muscle Society, or WMS, 2021 Virtual Congress: Sept. 20-24
3rd RAS-targeted Drug Development Summit: Sept. 21-23
5th Global Summit on Precision Diagnosis and Treatment of Prostate Cancer: Sept. 23-25
16th Meeting of the European Association of Neuro-oncology, or EANO: Sept. 25-26

PDUFA Dates

The FDA is scheduled to rule on Incyte Corporation (NASDAQ:INCY)'s new drug application for ruxolitinib cream in atopic dermatitis and a supplemental new drug application for ruxolitinib in steroid-refractory chronic graft-versus-host disease. The PDUFA dates for the two applications are Tuesday, Sept. 21 and Wednesday, Sept. 22, respectively.

Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) awaits an FDA decision on its NDA for VP-102 as a treatment option for molluscum contagiosum. The PDUFA date been set for Thursday, Sept. 23.

Clinical Readouts/Presentations

ESMO Congress Presentations

Novartis AG (NYSE:NVS): Overall survival results from the phase 3 MONALEESA-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative advanced breast cancer treated with endocrine therapy ± ribociclib (Sunday, Sept. 19, at 8:10 am)

Mirati Therapeutics, Inc. (NASDAQ:MRTX) & Zai Lab Limited (NASDAQ:ZLAB): Data from the CRYSTAL-1 Phase 1/2 study of adagrasib (MRTX849) as monotherapy or combined with cetuximab in patients with colorectal cancer harboring a KRASG12C mutation (Sunday, Sept. 19, at 9:47-9:52 am); Zai Labs has acquired Chinese rights to adagrasib; Phase 2 trial of sitravatinib + Bristol-Myers Squibb Company (NYSE:BMY)'s Opdivo in patients with non-squamous non–small cell lung cancer (Monday, Sept. 20, 8:20-8:30 am)

Veru, Inc. (NASDAQ:VERU): updated clinical data from the Phase 1b/2 study of sabizabulin (VERU-111) in metastatic castration resistant prostate cancer patients who have progressed on at least one novel androgen receptor targeting agent (Sunday, Sept. 19, at 11:30 am-12:10 pm)

Verastem, Inc. (NASDAQ:VSTM): Efficacy data from the Phase I study of the combination of VS-6766 and defactinib in low grade serous ovarian cancer (Sunday, Sept, 19 at 11:50-11:55 am)

Johnson & Johnson (NYSE:JNJ): analysis from the Phase 3 ACIS trial of Erleada and Zytiga (abiraterone acetate) plus prednisone in metastatic castration-resistant prostate cancer

Aprea Therapeutics, Inc. (NASDAQ:APRE): Phase 1/2 study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies (Monday, Sept. 20, at 11:35-11:40 am)

Related Link: Moderna Analysts Debate Need For Biopharma's COVID-19 Booster Shot

iwCLL Presentations

TG Therapeutics, Inc. (NASDAQ:TGTX): Phase 1/2 study of Umbralisib, Ublituximab, and Venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia. The presentation is scheduled for Sunday, Sept. 19, at 10:50 am. The company will also present on Sunday, Sept. 19 at 2 pm, data from the Phase 1 study of G-1701 as monotherapy and in combination with Ublituximab and Umbralisib in patients with chronic lymphocytic leukemia.

WMS Congress Presentations

Sarepta Therapeutics, Inc. (NASDAQ:SRPT): Safety, β-sarcoglycan expression, and functional outcomes from systemic gene transfer of rAAVrh74.MHCK7.SGCB in limb girdle muscular dystrophy type 2E/R4; interim results from the Phase 3 ESSENCE study of casimersen in patients with Duchenne muscular dystrophy amenable to exon 45 skipping; safety and efficacy data from the Phase 2 evaluating SRP-9001 for treating patients with Duchenne muscular dystrophy (Monday, Sept. 20)

Capricor Therapeutics, Inc. (NASDAQ:CAPR): final data from its HOPE-2 clinical trial with asset CAP-1002 in patients with late-stage Duchenne muscular dystrophy (Friday, Sept. 24, at 11:15 am to 12 pm)

Click here to access Benzinga's FDA Calendar

RAS-targeted Drug Development Summit Presentation

Onconova Therapeutics, Inc. (NASDAQ:ONTX): preliminary data from the Phase 1/2 study of rigosertib plus Opdivo in advanced KRAS-mutated NSCLC

Earnings

Applied Genetic Technologies Corporation (NASDAQ:AGTC) (Thursday, after the close)

IPOs

San Diego, California-based Cue Health, Inc. (NASDAQ:HLTH) is offering 12.5 million shares of its common stock in an initial public offering, estimated to be priced between $15 and $17. The healthcare tech company expects to list the shares on the Nasdaq under the ticker symbol "HLTH."

Related Link: Why This Citius Analyst Thinks The Biopharma's Shares Present 375% Upside Potential