The Daily Biotech Pulse: CorMedix Slumps On Delay In Resubmission of DefenCath NDA, Apellis Awaits FDA Decision, Vera Therapeutics Debuts

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 May 13)

• Alexion Pharmaceuticals, Inc. ALXN
• Novo Nordisk A/S NVO
• Vaccitech plc VACC

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 13)

• 4D Molecular Therapeutics, Inc. FDMT
• ADC Therapeutics SA ADCT
• Accelerate Diagnostics, Inc. AXDX
• Achilles Therapeutics plc ACHL
• Akouos, Inc. AKUS (announced its first-quarter results)
• Applied Genetic Technologies Corporation AGTC
• Aprea Therapeutics, Inc. APRE
• Aquestive Therapeutics, Inc. AQST
• Arcturus Therapeutics Holdings Inc. ARCT
• Atea Pharmaceuticals, Inc. AVIR
• Atreca, Inc. BCEL
• Bellerophon Therapeutics, Inc. BLPH
• Biomea Fusion, Inc. BMEA
• Capricor Therapeutics, Inc. CAPR
• Cellectis S.A. CLLS
• ContraFect Corporation CFRX
• Co-Diagnostics, Inc. CODX
• Decibel Therapeutics, Inc. DBTX
• Deciphera Pharmaceuticals, Inc. DCPH
• Design Therapeutics, Inc. DSGN
• Diffusion Pharmaceuticals Inc. DFFN
• Edgewise Therapeutics, Inc. EWTX
• Enveric Biosciences, Inc. ENVB
• Evoke Pharma, Inc. EVOK (reacted to its first-quarter results)
• Foghorn Therapeutics Inc. FHTX
• Gain Therapeutics, Inc. GANX
• Galecto, Inc. GLTO
• Galmed Pharmaceuticals Ltd. GLMD (announced its first-quarter results)
• Global Blood Therapeutics, Inc. GBT
• Gracell Biotechnologies Inc. GRCL
• Graybug Vision, Inc. GRAY
• Haemonetics Corporation HAE (announced its first-quarter results)
• Happiness Biotech Group Limited HAPP
• Harmony Biosciences Holdings, Inc. HRMY
• Hepion Pharmaceuticals, Inc. HEPA
• HTG Molecular Diagnostics, Inc. HTGM
• Idera Pharmaceuticals, Inc. IDRA
• Impel NeuroPharma, Inc. IMPL
• InflaRx N.V. IFRX
• Inhibikase Therapeutics, Inc. IKT
• Inozyme Pharma, Inc. INZY
• Instil Bio, Inc. TIL (announced its first-quarter results)
• Iovance Biotherapeutics, Inc. IOVA
• Kala Pharmaceuticals, Inc. KALA
• Kamada Ltd. KMDA
• Kiniksa Pharmaceuticals, Ltd. KNSA
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• La Jolla Pharmaceutical Company LJPC
• LogicBio Therapeutics, Inc. NASDAQ
• Longeveron Inc. LGVN
• Lyra Therapeutics, Inc. LYRA
• MediciNova, Inc. MNOV
• Mesoblast Limited MESO
• Metacrine, Inc. MTCR
• NeuBase Therapeutics, Inc. NBSE
• NeuroBo Pharmaceuticals, Inc. NRBO
• NeuroPace, Inc. NPCE
• NuCana plc NCNA
• Odonate Therapeutics, Inc. ODT
• Opthea Limited OPT
• Orgenesis Inc. ORGS
• Orphazyme A/S ORPH
• Outset Medical, Inc. OM
• Oyster Point Pharma, Inc. OYST
• Pharming Group N.V. PHAR (announced its quarterly results)
• Pharvaris N.V. PHVS
• Phio Pharmaceuticals Corp. PHIO
• Pluristem Therapeutics Inc. PSTI
• Praxis Precision Medicines, Inc. PRAX
• Protara Therapeutics, Inc. TARA
• PTC Therapeutics, Inc. PTCT
• Pulmonx Corporation LUNG
• Qualigen Therapeutics, Inc. QLGN
• Rain Therapeutics Inc. RAIN
• Reata Pharmaceuticals, Inc. RETA
• Recursion Pharmaceuticals, Inc. RXRX
• Relay Therapeutics, Inc. RLAY
• Reneo Pharmaceuticals, Inc. RPHM
• Scopus BioPharma Inc. SCPS
• Sensei Biotherapeutics, Inc. SNSE (announced its first-quarter results)
• Silverback Therapeutics, Inc. SBTX
• Soleno Therapeutics Inc SLNO
• Soligenix, Inc. SNGX
• Sonnet BioTherapeutics Holdings, Inc. SONN
• SQZ Biotechnologies Company SQZ
• Talaris Therapeutics, Inc. TALS
• Trevi Therapeutics, Inc. TRVI
• Universe Pharmaceuticals INC UPC
• UroGen Pharma Ltd. URGN (announced first-quarter results)
• Vallon Pharmaceuticals, Inc. VLON (reacted to quarterly results)
• VectivBio Holding AG VECT
• Virpax Pharmaceuticals, Inc. VRPX
• Viveve Medical, Inc. VIVE
• Vor Biopharma Inc. VOR
• Werewolf Therapeutics, Inc. HOWL
• Windtree Therapeutics, Inc. WINT (announced first-quarter results)

Stocks In Focus

Applied Genetic to Expand Manufacturing Facility For Gene Therapy Candidates, Secures $10M In additional Debt Funding

Applied Genetic said it has initiated plans to lease a build-to-suit 21,000 square foot current Good Manufacturing Practices manufacturing and quality control facility adjacent to its Florida facility to prepare for anticipated late-stage development of its X-Linked Retinitis Pigmentosa and Achromatopsia programs. The company expects the buildout to be completed in the second half of 2022, which will help rapid biologic license application filing and commercial launch of its XLRP candidate upon potential approval by the FDA.

The company also said it obtained an additional $10 million in debt and maturity extension under an amended loan agreement with Hercules,

The stock added 2.45% to $3.76 in after-hours trading.

BioDelivery Sciences Gains On Insider Buying

BioDelivery Sciences International, Inc. BDSI revealed in a filing Mark Sirgo, a director of its board, bought 15,500 shares of the company and Kevin Kotler, another director bought 300,000 shares.

The stock was up 9.12% to $3.47 in after-hours trading.

Offerings

Eloxx Pharmaceuticals, Inc. ELOX said it priced an underwritten public offering of 33.33 million shares of common stock at a public offering price of $1.35 per share.

The stock slumped 20.59% to $1.35 in after-hours trading.

Earnings

CorMedix Inc. CRMD reported a wider loss for the first quarter of 2021 but the loss per share narrowed due to an increase in the number of outstanding shares. Analysts, on average, estimated a loss of 18 cents per share.

The company stated on the earnings call additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA in the NDA for DefenCath as a treatment option for catheter-related bloodstream infection in hemodialysis patients. As a result, it expects to resubmit the NDA in the fourth quarter of 2021.

The stock plunged 31.22% to $5.20 in after-hours trading.

PolarityTE, Inc. PTE said its first-quarter revenues climbed from $3.59 million in 2020 to $4.7 million in 2021. The net loss per share narrowed from 53 cents to 12 cents.

The company also said in connection with transition to the BLA pathway and based on the FDA's recent announcement that enforcement discretion related to 361 HCT/P products will not be extended beyond May 31, 2021, it will cease commercial sales of SkinTE and wind down commercial operations. It is also planning to make substantial reductions in the costs associated with its commercial operations, which will mitigate the effect on cash flow resulting from the loss of SkinTE revenues.

The stock plunged 20.16% to 99 cents in after-hours trading,

BioNano Genomics Inc BNGO reported first-quarter revenues of $3.2 million for the first quarter, up 179% year-over-year. At March 31, the company had cash and cash equivalents of $362 million

The stock surged up 15.87% to $5.11 in after-hours trading.

On The Radar

PDUFA Dates

Apellis Pharmaceuticals, Inc.'s APLS new drug application for pegcetacoplan, being evaluated for paroxysmal nocturnal hemoglobinuria, has a PDUFA goal date of Friday.

Clinical Readouts

American Thoracic Society Meeting Presentations

Amgen Inc. AMGN and AstraZeneca PLC AZN: Additional data from the pivotal NAVIGATOR study evaluating Tezepelumab in patients with severe uncontrolled asthma.

Acceleron Pharma Inc. XLRN: Updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept in patients with pulmonary arterial hypertension

American Society of Gene and Cell Therapy Meeting Presentations

REGENXBIO Inc. RGNX: Interim analysis of the Phase 1 study of RGX-121 gene therapy for the treatment of severe mucopolysaccharidosis Type II

Athenex, Inc. ATNX: Additional GINAKIT2 Phase I data in neuroblastoma

Ultragenyx Pharmaceutical Inc. RARE: Updated results from a Phase 1/2 study of AAV8-mediated liver-directed gene therapy as a potential therapeutic option in adults with glycogen storage disease Type Ia (Friday)

Earnings

Forma Therapeutics Holdings, Inc. FMTX (before the market open)
PLx Pharma Inc. PLXP (before the market open)
Bio-Path Holdings, Inc. BPTH (before the market open)
Celsion Corporation CLSN (before the market open)
Protalix BioTherapeutics, Inc. PLX (before the market open)

IPOs

Vera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing treatments for serious immunological diseases, priced its initial public offering of 4.35 million shares of its Class A common stock at a price to the public of $11 per share. The gross proceeds to Vera from the offering are expected to be $47.85 million.

All of the shares are being offered by Vera. The shares are expected to begin trading on the Nasdaq under the ticker symbol "VERA."

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