BPC October 16 update

Aldeyra ALDX rallies on analyst coverage +18%; Agios AGIO withdraws European Marketing Authorization Application -5% AH

Price and Volume Movers

Aldeyra Therapeutics (NASDAQ: ALDX) shares closed up 18% to $8.10 following the initiation of coverage by analysts at BTIG, with a buy recommendation and a price target of $29.

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. The decision follows feedback from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) which noted data from its Phase 1 study do not sufficiently support a positive benefit-risk balance. Shares are trading down 5% to $33.90 after hours.

Adaptimmune Therapeutics (NASDAQ: ADAP) shares closed down 20% to $6.31. The company announced late Thursday its abstract for the upcoming SITC meeting on November 11, 2020. The company noted that 2 out of 5 patients, with head and neck and esophagogastric junction cancers, had achieved partial responses. In a previous update in May the company noted that there had been 3 partial responses but two were unconfirmed at that time, meaning that one of the unconfirmed responses was not confirmed as a partial response.

-

Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Selecta Biosciences, Inc. (SELB): $8.13; +19%.

ADiTx Therapeutics, Inc. (ADTX): $2.48; +18%.

AcelRx Pharmaceuticals, Inc. (ACRX): $1.89; +13%.

Histogen Inc. (HSTO): $2.24; +12%.

Catalyst Biosciences, Inc. (CBIO): $6.42; +11%.

DECLINERS:

Can-Fite BioPharma Ltd. (CANF): $1.82; -16%.

Galera Therapeutics, Inc. (GRTX): $10.66; -14%.

Sorrento Therapeutics, Inc. (SRNE): $9.33; -10%.

Alterity Therapeutics Limited (ATHE): $1.83; -10%.

Brainstorm Cell Therapeutics Inc. (BCLI): $13.90; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

IMRA – IMARA Inc.
IMR-687
b-thalassemia

Phase 2b Phase 2b trial initiation of dosing announced October 16, 2020.
$277.7 million

KZIA – Kazia Therapeutics Limited
GDC-0084
Glioblastoma

Phase 2/3 Pivotal trial enrollment to commence 1Q 2021.
$54.3 million

ORMP – Oramed Pharmaceuticals Inc.
ORMD-0801
Type 2 Diabetes

Phase 2b Phase 3 trial to commence patient enrollment 4Q 2020.
$58.6 million