The Week Ahead In Biotech (May 1-7): Phathom FDA Decision, Pfizer, Vertex Pharma Lead Earnings News, Ophthalmology Conference Presentations, And More

Zinger Key Points
  • Biotech stocks are going through a lean patch amid the broader market weakness
  • The unfolding week has several catalysts, including earnings, regulatory decisions and clinical data presentations

Biotech stocks posted weekly declines yet again in the week ending April 29, taking cues from the weak broader market sentiment. Big pharma earnings, clinical readouts and pipeline updates moved stocks during the week.

Molecular Partners AG (MOLN) was among the worst decliners of the week, reacting to potential issues with the emergency use authorization filing for its antiviral candidate and a loss of partnership with Amgen, Inc. AMGN.

On the other hand, Nektar Therapeutics NKTR and Vaxxinity, Inc. VAXX advanced strongly, with the former reacting to its reorganization and the latter to an update on its early-stage Parkinson's disease trials.

Here are the key catalysts scheduled for the unfolding week:

Conferences

Pediatric Endocrine Society, or PES, 2022 Annual Meeting: April 28-May 1 (virtual)
14th European Paediatric Neurology Society, or EPNS, Congress: April 28-May 2, in Glasgow, U.K.
13th European and Global CLINAM Summit for Nanomedicine: May 2-4 (virtual)
ESMO's Breast Cancer Congress 2022: May 3-5, in Berlin, Germany
Association for Research in Vision and Ophthalmology, or ARVO, 2022: May 1-4, in Denver, Colorado and virtually
2022 Synthetic Biology: Engineering, Evolution & Design (SEED): May 2-5, in Arlington, Virginia
The American Society of Interventional Pain Physicians, or ASIPP, 24th Annual Meeting: May 5-7, in Caesars Place, in Las Vegas
Genetic Metabolic Dieticians International, or GMDI, Conference: May 5-7

PDUFA Dates

The Food and Drug Administration is scheduled to rule on Phathom Pharmaceuticals, Inc.'s PHAT new drug applications for two vonoprazan combinations for treating Helicobacter pylori infection in adults. The PDUFA goal date is Tuesday, May 3.

Pfizer, Inc. PFE and Myovant Sciences, Inc. MYOV await approval of their supplemental NDA for Myfembree as a treatment option for the management of moderate-to-server pain associated with endometriosis. The PDUFA goal date is Friday, May 6. An FDA communication in April that informed deficiency in the application has toned down expectations for a positive decision by the PDUFA date.

Clinical Readouts/Presentations

ARVO Meeting Presentations

Ocular Therapeutix, Inc. OCUL: Phase 2 data for OTX-DED dexamethasone intracanalicular insert in subjects with dry eye disease (Monday)

Ocuphire Pharma, Inc. OCUP: Phase 3 data for nyxol eye drops for the reversal of mydriasis and Phase 2 data for nyxol, in combination with low-dose pilocarpine eye drops, in presbyopia (Monday)

Lineage Cell Therapeutics, Inc. LCTX: Phase 1/2a trial of transplanted allogeneic retinal pigmented epithelium (RPE, OpRegen) cells in advanced dry age-related macular degeneration (Monday)

ProQR Therapeutics N.V. PRQR: Long-term safety and efficacy of sepofarsen in a Ph1b/2 INSIGHT extension trial in CEP290-associated Leber congenital amaurosis (Tuesday)

Applied Genetic Technologies Corporation AGTC: interim safety results in two Phase 1/2 studies of subretinal gene therapy with AGTC-401 and AGTC-402 in subjects with achromatopsia (Tuesday) and Phase 1/2 data for subretinal gene therapy AGTC-501 for X-linked retinitis pigmentosa (Wednesday)

Kodiak Sciences Inc. KOD: Phase 2b/3 data for KSI-301 antibody biopolymer conjugate in wet AMD (Tuesday)

Unity Biotechnology, Inc. UBX:Phase 1 data for UBX1325, a treatment for patients with advanced diabetic macular edema or wet AMD (Wednesday)

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

SEED Meeting Presentations

Synlogic, Inc. SYBX: Phase 1 data SYNB1934, a synthetic biotic for Phenylketonuria (Monday)

CLINAM Summit Presentations

PolyPid Ltd. PYPD: Phase 2 data for D-Plex100 for abdominal sternal surgical site infections in colorectal surgery patients

ESMO Breast Cancer Conference Presentations

Immutep Limited IMMP: phase 2b study comparing eftilagimod alpha vs. placebo in combination with weekly paclitaxel in HR+ HER2- metastatic breast cancer (Wednesday)

GMDI Conference Presentations

Travere Therapeutics, Inc. TVTX: Phase 1/2 data for pegtibatinase, an enzyme replacement therapy for treating classical homocystinuria (Wednesday)

Synlogic: Phase 2 data for SYNB1618, a live biotherapeutic, for managing phenylketonuria (Thursday)

ASIPP Meeting Presentations

Sorrento Therapeutics, Inc.'s SRNE Scilex unit: SP-102 efficacy and safety data from the Pivotal Phase 3 clinical study

Earnings

The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule

Monday

Axsome Therapeutics, Inc. (AXSM) (before the market open)

Tuesday

Biogen Inc. BIIB (before the market open)
Pfizer Inc. PFE (before the market open)
Teva Pharmaceutical Industries Limited TEVA (before the market open)
Incyte Corporation INCY (before the market open)
Sage Therapeutics, Inc. SAGE (before the market open)

Wednesday

Amarin Corporation plc AMRN (before the market open)
Regeneron Pharmaceuticals, Inc. REGN (before the market open)
Sarepta Therapeutics, Inc. SRPT (after the close)

Thursday

Endo International plc ENDP (after the close)
Illumina, Inc. ILMN (after the close)
Vertex Pharmaceuticals Incorporated VRTX (after the close)

Friday

ImmunoGen, Inc. IMGN (before the market open)
Athersys, Inc. ATHX (before the market open)

IPOs

IPO Pricing

Bausch + Lomb Corporation BLCO, a wholly owned subsidiary of Bausch Health Companies Inc. BHC, is offering 35 million common shares in an initial public offering. The IPO price is currently expected to be between $21 and $24 per share. Bausch + Lomb has applied to list its common shares on the NYSE and the Toronto Stock Exchange, both under the ticker symbol "BLCO."

Related Link: RBC Capital Remains On Sidelines For This MedTech Stock

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