The Daily Biotech Pulse: Lilly's COVID-19 Antibody Treatment Approved For Emergency Use, Supernus Faces Twin Regulatory Setbacks, Revance, Arena Flunk Midstage Studies - iShares Biotechnology ETF (NASDAQ:IBB)

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 Nov. 9)

Alcon AG ALC
Aligos Therapeutics Inc ALGS
Aptevo Therapeutics Inc APVO (announced second complete remission in a patient in Cohort 6 of a Phase 1 study of AVO436 in acute myeloid leukemia and myelodysplastic syndrome patients)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
BIO-TECHNE Corp TECH
BioLife Solutions Inc BLFS
BioNTech SE – ADR BNTX - announced over 90% efficacy in the Phase 3 study of its coronavirus vaccine candidate co-developed with Pfizer Inc. PFE
C4 Therapeutics Inc CCCC
Calliditas Therapeutics Adr Rep 2 Ord Shs CALT (announced positive topline results from Part A of the Phase 3 clinical trial of Nefecon in patients with primary IgA nephropathy)
Catalent Inc CTLT
Denali Therapeutics Inc DNLI
Fate Therapeutics Inc FATE
Halozyme Therapeutics, Inc. HALO
Harmony Biosciences Holdings Inc HRMY
Immunovant Inc IMVT
Inspire Medical Systems Inc INSP
Insulet Corporation PODD
Intellia Therapeutics Inc NTLA (announced dosing of first patient in the CRISPR/Cas9 trial of NTLA-2001 in transthyretin amyloidosis)
Intuitive Surgical, Inc. ISRG
Kalvista Pharmaceuticals Inc KALV
Kodiak Sciences Inc KOD (reacted to its third-quarter results)
Kura Oncology Inc KURA
Kymera Therapeutics Inc KYMR
Larimar Therapeutics Inc LRMR
Merit Medical Systems, Inc. MMSI
Neuronetics Inc STIM
Nevro Corp NVRO
Ocular Therapeutix Inc OCUL
Pacific Biosciences of California Inc PACB
Pfizer (reacted to its vaccine readout)
PTC Therapeutics, Inc. PTCT
ResMed Inc. RMD
Silk Road Medical Inc SILK
Shockwave Medical Inc SWAV
Stoke Therapeutics Inc STOK
Sutro Biopharma Inc STRO
Tcr2 Therapeutics Inc TCRR
Twist Bioscience Corp TWST
Ultragenyx Pharmaceutical Inc RARE
Veracyte Inc VCYT
Vericel Corp VCEL
West Pharmaceutical Services Inc. WST
Y-mAbs Therapeutics, Inc YMAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 9)

Atea Pharmaceuticals, Inc. AVIR
Bellicum Pharmaceuticals Inc BLCM
Biodesix Inc BDSX
Biogen Inc BIIB (reacted to negative Adcom vote for its Alzheimer's disease drug)
Biondvax Pharmaceuticals Ltd – ADR BVXV
Galmed Pharmaceuticals Ltd GLMD (announced R&D collaboration for development of a standalone, microbiome-based treatment for non-alcoholic steatohepatitis and fibrosis)
Lexicon Pharmaceuticals, Inc. LXRX
Monopar Therapeutics Inc MNPR
Nabriva Therapeutics PLC – ADR NBRV
Ocuphire Pharma Inc OCUP
Polarityte Inc PTE (reacted to third-quarter results)
Qualigen Therapeutics Inc QLGN
Repro-Med Systems, Inc. KRMD

Stocks In Focus

Affimed Strikes Licensing Agreement Targeting Multiple Cancers

Affimed NV AFMD announced a licensing and strategic collaboration agreement with Roivant Sciences, under which Affimed has granted Roivant the license to the preclinical molecule AFM32. The agreement also allows for the leveraging of Affimed's proprietary, redirected cell-killing platform to generate ICE molecules for oncology against targets not included in Affimed's present pipeline.

The agreement provides for Affimed receiving $60 million in upfront consideration, comprised of $40 million in cash and prepaid R&D funding, and $20 million of newly issued shares in Roivant.

Affimed could receive further short-term proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The company is also eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

Affimed shares were up 13.67% at $4.24 premarket Tuesday.

Supernus' ADHD Drug Issued Complete Response Letter, Parkinson's Disease Drug Regulatory Filing Rejected By FDA

Supernus Pharmaceuticals Inc SUPN said the FDA issued a complete response letter for SPN-812 for the treatment of ADHD in pediatric patients ages 6 to 17.

The primary issue cited in the CRL relates to Supernus' in-house laboratory, which conducts analytical testing and recently moved to a new location.

The company said it plans to discuss with the FDA the contents of the CRL and clarify to the FDA that the application does not rely solely on this facility for product release. No clinical safety or efficacy issues were identified during the review, Supernus said.

Supernus also said it received a refusal-to-file letter from the FDA regarding its NDA for SPN-830 for the continuous treatment of motor fluctuations, or on-off episodes, in Parkinson's disease.

In the letter, the FDA requested certain documents and reports to be submitted in support of the application.

The company said it plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN-830.

The stock was down 19.24% at $20.15 premarket Tuesday.

Altimmune Strikes Vaccine Manufacturing Deal With Lonza, Reports Q3 Beat

Altimmune Inc ALT said it entered into an agreement with CDMO Lonza for the manufacturing of AdCOVID, its single-dose intranasal COVID-19 vaccine candidate. Lonza has facilities in Europe, North America, and South Asia.

Separately, Altimmune reported an increase in its third-quarter revenues from $640,000 in 2019 to $2.94 million. Its net loss per share narrowed from 74 cents to 54 cents. Analysts had estimated a loss of 76 cents per share on revenue of $1.05 million.

The stock was trading 10.78% higher at $8.68 premarket.

Lilly COVID-19 Antibody Treatment Receives Emergency Use Authorization

Eli Lilly And Co LLY said the FDA has issued emergency use authorization for its investigational neutralizing antibody bamlanivimab 700 mg, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Lilly said it will begin shipping bamlanivimab immediately to AmerisourceBergen Corp. ABC, a national distributor, which will distribute it as directed by the U.S. government's allocation program.

Lilly shares were up 3.28% premarket at $147.

Merck To Halt Keytruda-Yervoy Combo Study In Some Lung Cancer Patients

Merck & Co., Inc. MRK said it will stop the KEYNOTE-598 study, a Phase 3 trial investigating Keytruda, in combination with Bristol-Myers Squibb Co's BMY Yervoy, compared with Keytruda monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1, with no EGFR or ALK genomic tumor aberrations.

Merck attributed the discontinuation to the recommendation of an independent Data Monitoring Committee, which determined the benefit/risk profile of the combination did not support continuing the trial.

At an interim analysis, the combination showed no incremental benefit in overall survival or progression-free survival, the study's dual primary endpoints, compared with Keytruda monotherapy, Merck said.

Merck shares were up 0.25% at $80.70 premarket.

Revance's Drug Flunks Midstage Study In Heel Muscle Inflammation, Biopharma Reports Wider-Than-Expected Loss

Revance Therapeutics Inc RVNC announced results from its Phase 2 clinical trial of the investigational drug candidate DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, showing that both the evaluated doses did not met the primary efficacy endpoint of statistically significant improvement from baseline in the NPRS for foot pain at week eight, compared to placebo.

Separately, the company reported a wider-than-expected loss for the third quarter.

The stock fell 5.80% to $26 in after-hours trading.

Arena's Atopic Dermatitis Drug Did Not Meet Primary Endpoint In a Phase 2b Study

Arena Pharmaceuticals, Inc. ARNA said the Phase 2b ADVISE clinical trial evaluating etrasimod for the treatment of moderate-to-severe atopic dermatitis did not meet the primary endpoint of eczema area and severity index change from baseline at week 12 as compared to placebo.

Separately, the company reported a narrower-than-expected loss for the third quarter.

The stock ended down 17.66% to $71.98 in after-hours trading.

NantKWest Reports Positive Interim Data For COVID-19 Vaccine

Nantkwest Inc NK and ImmunityBio, a privately held immunotherapy company, announced positive interim Phase 1 data for their second-generation bivalent, human adenovirus COVID-19 vaccine hAd5.

Novavax Appoints CFO, Reports Below-Consensus Q3 Results

Novavax, Inc. NVAX announced the appointment of Gregory Covino as CFO. John Trizzino, who previously served as CFO, will now become chief commercial officer while continuing in his role as chief business officer, the company said.

Separately, the company reported a third-quarter loss of $3.21 per share on revenue of $157 million. Analysts, on average, were modeling EPS of $1.73 on revenue of $230.56 million

In premarket trading, the stock was down 5.87% at $85.01.

Earnings

Fulgent Genetics Inc FLGT said its third-quarter revenue jumped 880% year-over-year to $101.7 million, and non-GAAP net income climbed from 14 cents per share to $2.08 per share.

The company raised its full-year revenue guidance.

The stock rallied 16.74% to $36.20 in after-hours trading.

Neurocrine Biosciences, Inc. NBIX said its third-quarter revenue increased from $222.1 million in 2019 to $258.5 million in 2020. The company's earnings on a non-GAAP basis, increased from 90 cents per share to 97 cents per share.

In after-hours trading, the stock plunged 12.5% to $89.96.

Offerings

TherapeuticsMD Inc TXMD announced an underwritten public offering of its common stock. The company said it intends to use the net proceeds from the offering for commercialization of its three FDA-approved products, and also for working capital and general corporate purposes.

The stock slumped 13.16% to $1.32 in after-hours trading.

On The Radar

Earnings

Fulcrum Therapeutics Inc FULC (before the market open)
STRATA Skin Sciences Inc SSKN (before the market open)
Aerpio Pharmaceuticals Inc ARPO (before the market open)
Mediwound Ltd MDWD (before the market open)
Altimmune Inc ALT (before the market open)
BioNTech SE – ADR BNTX (before the market open)
Corbus Pharmaceuticals Holdings Inc CRBP (before the market open)
Affimed NV AFMD (before the market open)
Zogenix, Inc. ZGNX (after the close)
10X Genomics Inc TXG (after the close)
Adaptive Biotechnologies Corp ADPT
Clearside Biomedical Inc CLSD (after the close)
Viela Bio Inc VIE (after the close)
CTI BioPharma Corp CTIC (after the close)
Curis, Inc. CRIS (after the close)
Clearpoint Neuro Inc CLPT (after the close)
Cumberland Pharmaceuticals, Inc. CPIX (after the close)
HTG Molecular Diagnostics Inc HTGM (after the close)
Eyenovia Inc EYEN (after the close)
TRACON Pharmaceuticals Inc TCON (after the close)
Lumos Pharma Inc LUMO (after the close)
Silk Road Medical Inc SILK (after the close)
Osmotica Pharmaceuticals PLC OSMT (after the close)
DermTech Inc DMTK (after the close)
Precision BioSciences Inc DTIL
Passage Bio Inc PASG
Gamida Cell Ltd GMDA
Synthetic Biologics Inc SYN
Gossamer Bio Inc GOSS

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