The Daily Biotech Pulse: Early Approval For Ascendis' Pediatric Growth Hormone Deficiency Treatment, Redhill Biopharma Spikes On Positive COVID-19 Drug Data, RenovoRx IPO

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. 25)

  • Abbvie Inc. ABBV
  • BioLife Solutions, Inc. BLFS (reacted to the news of inclusion in the S&P SmallCap 600 Index)
  • Bio-Rad Laboratories, Inc. BIO
  • Catalent Inc CTLT
  • Celldex Therapeutics, Inc. CLDX
  • Dynavax Technologies Corporation DVAX
  • Fulcrum Therapeutics, Inc. FULC
  • Medtronic plc MDT
  • MiMedx Group, Inc. MDXG
  • Monte Rosa Therapeutics, Inc. GLUE
  • Nuvalent, Inc. NUVL (IPOed July 29)
  • PDS Biotechnology Corporation PDSB
  • Regencell Bioscience Holdings Limited RGC
  • Repligen Corporation RGEN
  • ShockWave Medical, Inc. SWAV
  • Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 25)

  • Aerovate Therapeutics, Inc. AVTE
  • Alzamend Neuro, Inc. ALZN
  • Theravance Biopharma, Inc. TBPH
  • TScan Therapeutics, Inc. TCRX

Stocks In Focus

Ascendis Gets FDA Nod For Pediatric Growth Hormone Deficiency Treatment

Ascendis Pharma A/S ASND said the Food and Drug Administration has approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone.

As a once-weekly injection, Skytrofa is the first FDA approved product that delivers somatropin by sustained release over one week, the company said. The company expects to make the drug available in the U.S. shortly, supported by a full suite of patient support programs.

Separately, the company reported lower revenues and a wider loss for the second quarter.

The stock is seen moving up 23.15% at $152.29 in premarket trading.

Codexis Receives Purchase Orders For High-Performance Enzyme Valued At $15M

Codexis, Inc. CDXS said it has received new purchase orders with an aggregate total value of approximately $15 million for the supply of a proprietary high performance enzyme used to manufacture a critical intermediate for an active pharmaceutical ingredient in a therapeutic drug for an undisclosed global pharmaceutical company. 

These orders were anticipated and included in the 2021 guidance Codexis provided Aug. 5 for total revenues, the company said.

Amneal Announces Positive Late-Stage Data For IPX-203 In Parkinson's Disease

Amneal Pharmaceuticals, Inc. AMRX announced positive topline results from the pivotal Phase 3 RISE-PD clinical trial that evaluated its IPX-203 in patients with Parkinson's disease who have motor fluctuations. The trial met its primary endpoint, demonstrating superior "Good On" time from baseline in hours per day at the end of the 13-week double-blind treatment period with IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD.

Based on these topline results plus other supportive data, Amneal said it plans to submit a new drug application for IPX-203 with the FDA in mid-2022.

In premarket trading, the stock was advancing 7.03% to $5.94.

Thermo Fisher's Companion Diagnostic Test For Servier's Biliary Duct Cancer Drug Approved By FDA

Thermo Fisher Scientific Inc. TMO said the FDA has granted pre-market approval to its Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 mutated cholangiocarcinoma, who may be candidates for Servier Pharmaceuticals' Tibsovo.

Tibsovo is an IDH1 inhibitor that is approved for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test.

Thermo Fisher's stock was found edging up 0.35% to $550 in premarket trading.

BeyondSpring Strikes Partnership To Market Plinabulin In Greater China

BeyondSpring BYSI and Jiangsu Hengrui Pharmaceuticals announced an exclusive commercialization and co-development agreement in Greater China for BeyondSpring's investigational drug candidate plinabulin, which in combination with G-CSF is currently under priority review by the FDA and the China National Medical Products Administration for the prevention of chemotherapy-induced neutropenia.

In premarket trading, the stock was moving 4.28% higher to $26.32.

Related Link: The Week Ahead In Biotech: Cara FDA Decision, Ascendis Earnings, Aileron Data Presentation And More

Redhill Biopharma's Opaganib Found To Strongly Inhibit Delta Variant In Animal Study

Redhill Biopharma Limited RDHL announced preliminary results of a new preclinical study showing strong inhibition by opaganib of delta variant replication while maintaining cell viability at relevant concentrations.

This work adds to the previously reported work that showed opaganib also inhibits alpha, beta and gamma SARS-CoV-2 variants, it added.

The stock was up 14.76% at $8.24 in premarket trading.

Merck's Keytruda Gets Two Approvals In Japan

Merck & Co., Inc. MRK said it has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency for Keytruda.

Keytruda is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2-negative, inoperable or recurrent breast cancer and as a monotherapy for the treatment of patients with unresectable, advanced or recurrent high microsatellite instability colorectal cancer.

BioCryst's Regulatory Applications For Hereditary Angioedema Drug Accepted For Review In Canada and Switzerland

BioCryst Pharmaceuticals, Inc. BCRX announced that the new drug submission for Orladeyo has been accepted for review by Health Canada for the prevention of recurrent attacks in patients with hereditary angioedema 12 years and older.

The company also announced that Swissmedic has accepted BioCryst's marketing authorization application for Orladeyo for review.

InMune Announces Positive Biomarker Data For NK Cell Therapy In Myelodysplastic Syndrome

INmune Bio, Inc. INMB announced that the first patient who received INKmune as a potential treatment for high-risk myelodysplastic syndrome has successfully shown the NK activation and functional differentiation predicted by previously published in vitro experiments.

On The Radar

Clinical Readouts

Annovis Bio, Inc. ANVS will present at the Biomarkers for Alzheimer's Disease Summit 2021, positive biomarker data that corroborates the positive efficacy data in two Phase 2 studies with ANVS401.


Los Altos, California-based RenovoRx, Inc. RNXT priced its initial public offering of up to1.85 million units of securities at $9 per unit. Each unit comprises one share of common stock and a warrant to purchase one share of common stock at an exercise price of $10.80 per share.

The gross proceeds to RenovoRx from the offering are expected to be $16.65 million. The company‘s shares have been approved for listing on the Nasdaq under the ticker symbol "RNXT."

RenovoRx is a clinical-stage biopharma focused on developing therapies for the local treatment of solid tumors and is currently conducting a Phase 3 registrational trial for its lead product candidate RenovoGem.

Biotricity, Inc. BTCY, a medical diagnostic and consumer health care technology company, said it intends to offer shares of its common stock for sale in an underwritten public offering. In connection with the offering, the company's common stock is expected to be listed on the Nasdaq under the symbol "BTCY."

The company said it intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, working capital, potential acquisitions and other business opportunities.

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

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