The Daily Biotech Pulse: Pfizer's Positive Readout, NRx Strikes R&D Collaboration With Mannkind, Cerus & Invitae Jump On Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 3)

Absci, CORP ABSI (IPOed July 22)
Alkermes plc ALKS
Amphastar Pharmaceuticals, Inc. AMPH
Bio-Rad Laboratories, Inc. BIO
Bristol-Myers Squibb Company BMY
BioNTech SE BNTX
Cytek Biosciences, Inc. CTKB (IPOed July 23)
Eli Lilly and Company LLY (announced its second-quarter results)
Genmab A/S GMAB
Imago BioSciences, Inc. IMGO (IPOed July 16)
Immuneering Corporation IMRX (IPOed Friday)
Innoviva, Inc. INVA
Intuitive Surgical, Inc. ISRG
Johnson & Johnson JNJ
Maravai LifeSciences Holdings, Inc. MRVI
Moderna, Inc. MRNA (announced commencement of Phase 1 study of mRNA therapeutic candidate for autoimmune disorder)
Monte Rosa Therapeutics, Inc. GLUE
Myriad Genetics, Inc. MYGN
Novo Nordisk A/S NVO
Nuvalent, Inc. NUVL (IPOed Thursday)
Pfizer Inc. PFE
Quest Diagnostics Incorporated DGX
Repligen Corporation RGEN
ResMed Inc. RMD
Translate Bio, Inc. TBIO (announced a deal to be bought by Sanofi SNY

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 3)

Adicet Bio, Inc. ACET
Akero Therapeutics, Inc. AKRO
Alzamend Neuro, Inc. ALZN
Arena Pharmaceuticals, Inc. ARNA
Aridis Pharmaceuticals, Inc. ARDS
Avidity Biosciences, Inc. RNA
Aytu Biopharma, Inc. AYTU
Cara Therapeutics, Inc. CARA
Catalyst Pharmaceuticals, Inc. CPRX
Centessa Pharmaceuticals Limited CNTA
Cogent Biosciences, Inc. COGT
Deciphera Pharmaceuticals, Inc. DCPH
Ensysce Biosciences, Inc. ENSC
Esperion Therapeutics, Inc. ESPR (reacted to its quarterly results)
Epizyme, Inc. EPZM
Foghorn Therapeutics Inc. FHTX
Gemini Therapeutics, Inc. GMTX
Global Blood Therapeutics, Inc. GBT
Harpoon Therapeutics, Inc. HARP
Hepion Pharmaceuticals, Inc. HEPA
Heron Therapeutics, Inc. HRTX
Immunovant, Inc. IMVT
Innate Pharma S.A. IPHA
Insmed Incorporated INSM
Karyopharm Therapeutics Inc. KPTI
Kiniksa Pharmaceuticals, Ltd. KNSA
Kinnate Biopharma Inc. KNTE
Liquidia Corporation LQDA
Lyra Therapeutics, Inc. LYRA
Mersana Therapeutics, Inc. MRSN
Minerva Neurosciences, Inc. NERV
Moleculin Biotech, Inc. MBRX
Nautilus Biotechnology, Inc. NAUT
Nektar Therapeutics NKTR
Neoleukin Therapeutics, Inc. NLTX
NuCana plc NCNA
Orchard Therapeutics plc ORTX
ORIC Pharmaceuticals, Inc. ORIC
Orphazyme A/S ORPH
Oyster Point Pharma, Inc. OYST
Palisade Bio, Inc. PALI
Panbela Therapeutics, Inc. PBLA
Passage Bio, Inc. PASG
Plus Therapeutics, Inc. PSTV
Praxis Precision Medicines, Inc. PRAX
Progenity, Inc. PROG
Pulmatrix, Inc. PULM
Puma Biotechnology, Inc. PBYI
Reviva Pharmaceuticals Holdings, Inc. RVPH
Rhythm Pharmaceuticals, Inc. RYTM (reacted to its second-quarter results)
Sage Therapeutics, Inc. SAGE ( reacted to pipeline update and its second-quarter results)
Spruce Biosciences, Inc. SPRB
Teligent, Inc. TLGT
Terns Pharmaceuticals, Inc. TERN
TFF Pharmaceuticals, Inc. TFFP
Trillium Therapeutics Inc. TRIL
Vivos Therapeutics, Inc. VVOS
Vor Biopharma Inc. VOR
VYNE Therapeutics Inc. VYNE
Xeris Pharmaceuticals, Inc. XERS
ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Pfizer Announces Positive Phase 2b/3 Results For Autoimmune Disease That Causes Hair Loss

Pfizer announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients with alopecia areata, an autoimmune disease driven by an immune attack on the hair follicles that causes hair loss on the scalp and can also affect the face and body.

Ritlecitinib 50 mg and 30 mg achieved the primary efficacy endpoint of the study, namely the proportion of patients with less than or equal to 20 percent scalp hair loss after six months of treatment versus placebo.

The stock was up 1.05% at $46.16 in premarket trading.

BioNTech Gains On Closure of Acquisition of Kite R&D Platform and Manufacturing Facility

BioNTech announced the closing of the acquisition of the solid tumor neoantigen T cell receptor R&D platform and clinical manufacturing facility's assets and leases in Gaithersburg from Kite. The transaction was announced on July 19.

The stock was up 2.74% to $361.45 in premarket trading.

Click here to access Benzinga's FDA Calendar

Zymergen Sinks On Delay In Commercial Product Delivery, Terminates CEO

Zymergen, Inc. ZY said it recently became aware of issues with its commercial product pipeline that will impact its delivery timeline and revenue projections. Accordingly, the company said it no longer expects product revenue in 2021, and expects product revenue to be immaterial in 2022.

The company noted that several key target customers encountered technical issues in implementing Hyaline into their manufacturing processes typical of new product and process development learnings.

The company also announced the stepping down of its Josh Hoffman as CEO and as a member of the board, effective immediately.

Zymergen preannounced June quarter revenues of $5 million to $6 million and operating expenses of $100 million to $105 million.

The stock was plunging 71.83% to $9.81 in premarket trading.

ObsEva Announces Publication of Positive Mid-stage Results For Nolasiban In Improving Pregnancy Following IVF

ObsEva SA OBSV Announced the publication of two peer-reviewed papers on nolasiban that is being developed for improving live birth rates in women undergoing embryo transfer following in-vitro fertilization.

The company noted that Phase 2 IMPLANT1 and Phase 3 IMPLANT 2 trials both demonstrated that administration of a single 900 mg dose of nolasiban administered before fresh single embryo transfer increased live birth rates compared to placebo. These results were not confirmed in a third trial, IMPLANT 4.

A patient-level combined analysis of the three studies showed a 5% absolute increase in ongoing pregnancy rate, with an odds ratio for nolasiban versus placebo of 1.25 that was statistically significant. The study also showed that the 900mg dose was well tolerated.

The stock was up 5.60% at $2.64 in premarket trading.

NRx Partners With Mannkind to Develop Zyesami Inhaler For Inflammatory Conditions

NRx Pharmaceuticals NRXP announced it has signed an agreement with MannKind Corporation MNKD to develop a dry powder formulation of Zyesami, a synthetic form of human vasoactive intestinal peptide, produced by the body to help protect cells against inflammatory conditions.

Development will be based on MannKind's proven Technosphere platform, that is the basis of the Food and Drug Administration (FDA)-approved Afrezza inhaled insulin product.

Mannkind was adding 6.52% to $4.25 in premarket trading Tuesday, while NRx was rising 5.93% to $16.97.

Earnings

Cerus Corporation's CERS second-quarter revenues climbed 41% to $37.8 million and the loss per share was flat at 9 cents. The revenues exceeded estimated, while the loss was in line.

The stock was up 14.04% at $5.85 in after-hours trading.

Global Blood Therapeutics, Inc. GBT said its second-quarter revenues increased from $31.5 million in 2020 to $47.56 million in 2021. The company's net loss per share widened from 86 cents per share to $1.12 per share. The results exceeded estimates.

In premarket trading, the stock was up 16.03% to $31.20.

Aquestive Therapeutics, Inc. AQST said its revenues fell from $21.7 million in the second quarter of 2020 to $15.3 million in the second quarter of 2021. The loss per share widened from 7 cents to 33 cents.

The results exceeded estimates.

The stock was seen rising 13.85% to $ 3.7 in premarket trading.

OraSure Technologies, Inc.'s OSUR second-quarter revenues climbed 97% to $57.6 million. The loss per share narrowed from 16 cents to 2 cents. The company guided second-quarter revenues to $45 million to $50 million. The results and the guidance trailed expectations.

The stock was retreating 8.22% to $11.39 in premarket trading.

Invitae Corporation NVTA reported second-quarter revenues of $116.3 million, up 152% year-over-year. The net loss per share narrowed from $1.29 to 64 cents.

The stock was advancing 12.07% to $31.94 in premarket trading.

On The Radar

Earnings

TherapeuticsMD, Inc. TXMD (before the market open)
Intellia Therapeutics, Inc. NTLA (before the market open)
Surmodics, Inc. SRDX (before the market open)
Vericel Corporation VCEL (before the market open)
UroGen Pharma Ltd. URGN (before the market open)
Horizon Therapeutics Public Limited Company HZNP (before the market open)
IVERIC bio, Inc. ISEE (before the market open) (before the market open)
Flexion Therapeutics, Inc. FLXN (after the close)
Aerie Pharmaceuticals, Inc. AERI (after the close)
AxoGen, Inc. AXGN (after the close)
INmune Bio, Inc. INMB (after the close)
Bionano Genomics, Inc. BNGO (after the close)
DermTech, Inc. DMTK (after the close)
Fate Therapeutics, Inc. FATE (after the close)
G1 Therapeutics, Inc. GTHX (after the close)
Otonomy, Inc. OTIC (after the close)
Xencor, Inc. XNCR (after the close)
Celyad Oncology SA CYAD (after the close)