Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 20)

• 10X Genomics Inc TXG
• Avenue Therapeutics Inc ATXI
• Cardiff Oncology Inc CRDF
• Castle Biosciences Inc CSTL
• Fortress Biotech FBIO
• Fulgent Genetics Inc FLGT
• Keros Therapeutics Inc KROS
• Merit Medical Systems, Inc. MMSI
• Nurix Therapeutics Inc NRIX
• Otonomy Inc OTIC
• Pacific Biosciences of California Inc PACB
• Shockwave Medical Inc SWAV
• Tandem Diabetes Care Inc TNDM
• Trillium Therapeutics Inc TRIL
• Vaxcyte Inc PCVX

Down In The Dumps (Biotech Stocks Hitting 52-week Lows Aug. 20)

• Alector Inc ALEC
• Entera Bio Ltd ENTX
• Harmony Biosciences Holdings Inc HRMY (IPOed Wednesday)
• Histogen Inc HSTO
• Inhibrx Inc INBX (IPOed Wednesday)
• Iterum Therapeutics PLC ITRM
• NanoVibronix Inc NAOV
• Predictive Oncology Inc POAI
• Recro Pharma Inc REPH
• Sonnet BioTherapeutics SONN
• Teligent Inc TLGT
• Unity Biotechnology Inc UBX

Stocks In Focus

Xeris Promotes Shannon to Role of President and COO

Xeris Pharmaceuticals Inc (XERS) said its board has promoted John Shannon to the position of president and COO, effective immediately. Shannon will continue to report to Paul Edick, who serves as Xeris' chairman and CEO, it added.

In after-hours trading, the stock was up 6.57% to $4.54.

Renalytix AI, AstraZeneca Forge Partnership For Precision Medicine Strategies

Renalytix AI PLC RNLX and AstraZeneca plc AZN announced a collaboration to develop and launch precision medicine strategies for cardiovascular, renal and metabolic diseases.

The first stage in the collaboration will use KidneyIntelX, an artificial intelligence-enabled in vitro diagnostic platform, to examine further improving outcomes for patients with chronic kidney disease and its complications, in coordination with the Mount Sinai Health System.

Based on study outcomes, a multi-center, randomized controlled trial will be initiated to evaluate uptake and adherence to new potassium-binding agents in patients with CKD and hyperkalemia, the companies said.

The companies said results from the program are anticipated in early 2021.

Astellas Announces Death of A Patient Receiving Higher Dose of Investigational Gene Therapy In Rare Neuromuscular Disease

ASTELLAS PHARMA's/ADR (ALPMY) Audentes unit said a third study patient has passed away in the ASPIRO clinical trial evaluating investigational gene therapy AT132 in patients with X-linked Myotubular Myopathy, with the immediate cause being gastrointestinal bleeding.

The patient was one of the three patients, who received AT132 at a higher dose of 3x1014 vg/kg and began to demonstrate signs of liver dysfunction within 3 to 4 weeks after dosing.

Pfizer, BioNTech Announces Additional Positive Phase 1 Data for Coronavirus Vaccine

Pfizer Inc. (PFE) and BioNTech SE – (ADR BNTX) shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162b2 vaccine candidate, showing a second dose of 30mcg, seven days after the first dose, elicited SARS-CoV-2-neutralizing geometric mean titers, or GMTs in younger adults that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients.

In older adults, the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.

Tiziana Awarded Patent For Investigational Compound In Combination With Tyrosine Kinase Inhibitors For Cancer

TIZIANA LF SCIE/S ADR (TLSA) announced the award of a patent on use of Milciclib in combination with tyrosine kinase inhibitors such as Sorafenib, Regorafenib and Lenvatinib for the treatment of hepatocellular carcinoma and other cancers in humans.

In pre-market trading Friday, the stock was up 5.13% to $4.30.

J&J Gets Label Expansion For Darzalex

Johnson & Johnson's (JNJ) Janssen unit said the FDA approved Darzalex in combination Kyprolis and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.

The company had licensed the drug from GENMAB A/S/S (ADR GMAB).

Auris Regains Compliance With Nasdaq Listing Standard of Minimum Bid Requirement

Auris Medical Holding Ltd (EARS) said it has been notified by the Nasdaq that its stock had regained compliance with the Minimum Bid Price Requirement for continued listing on Nasdaq, and that the matter is now closed.

The stock rose 4.59% to $1.14 in after-hours trading.

Sorrento Agrees to Buy R&D Partner SmartPharm For $19.4M In Stock

Sorrento Therapeutics Inc (SRNE) announced an agreement to acquire SmartPharm, a gene-encoded therapeutics company developing non-viral DNA and RNA gene delivery platforms for COVID-19 and rare diseases.

SmartPharm equity holders will receive up to an aggregate of $19.4 million of shares of Sorrento common stock.

The companies already have a R&D collaboration to encode and express in vivo Sorrento's proprietary SARS-CoV-2 neutralizing monoclonal antibodies utilizing SmartPharm's Gene Mab plasmid nanoparticle platform.

The stock gained 3.11% to $11.27 in after-hours trading.

On The Radar

IPOs

Kymera Therapeutics, Inc., (KYMR - Pending) a biopharma focused on discovering and developing novel small molecule therapeutics, priced its upsized initial public offering of 8.685 million shares at $20 per share, above the estimated price range of $16-$18. The gross proceeds of the offering are expected to be approximately $173.7 million.

The shares are to be listed on the Nasdaq under the ticker symbol KYMR.