BPC December 03 update

Upcoming small and mid cap regulatory catalysts; Biotech week in review

Weekly watchlist

This week we revisit our fourth quarter watchlist of regulatory events to highlight those that have yet to occur. We supplement our list with other regulatory events remaining for the quarter. Next week we will highlight notable presentations from the American Society of Hematology (ASH) conference being held December 11-14, 2021.

First, however, let’s review the week that was with price-moving events.

REGULATORY UPDATES:

BeyondSpring Pharmaceuticals (NASDAQ: BYSI) closed the week down 74% at $4.02, after it received a Complete Response Letter (CRL) from the FDA regarding its application for linabulin in combination with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN).

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that the FDA plans for an Advisory Committee regarding its application for ublituximab and UKONIQ (umbralisib) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The meeting is set for March or April 2022, thus its March 25, 2022 PDUFA date will likely not be met. Shares closed the week down 35% at $15.64.

Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) announced that the FDA approved expanded labeling for Caldolor, an intravenously delivered form of ibuprofen, to now include use in pre-operative administration. Shares closed the week up 106% at $4.59.

The FDA extended the review period for CTI BioPharma Corp.’s (NASDAQ: CTIC) New Drug Application (NDA) for pacritinib to treat myelofibrosis (MF) by three months. Its new PDUFA date is February 28, 2022. Shares closed the week down 38% at $1.61.

Longeveron, Inc. (NASDAQ: LGVN) announced that the FDA granted Orphan Drug Designation (ODD) to Lomecel-B to treat Hypoplastic left heart syndrome (HLHS). Shares closed the week down 37% at $20.12.

CLINICAL UPDATES:

Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) released initial data from its Phase 1/2 trial of OP-1250 to treat breast cancer. Olema reported an overall response rate of 17%, and that only 32% of patients remain in the study. Shares closed the week down 51% at $10.47.

Drug Price Stage Catalyst Market Cap

AQST – Aquestive Therapeutics Inc.
Libervant (diazepam)
Epileptic seizures

$2.95
-0.35  -11%
PDUFA CRL announced September 25, 2020. NDA resubmitted with new PDUFA date December 23, 2021. Letter from FDA December 21, 2021, noting PDUFA date will not be met. No further information provided.
$118.5 million

ARGX – argenx SE
VYVGART (efgartigimod alfa-fcab)
Myasthenia gravis (MG)

$279.25
-2.23  -1%
Approved Approved December 17, 2021.
$14.4 billion

CALT – Calliditas Therapeutics AB
TARPEYO (budesonide)
IgA nephropathy

$21.12
-1.10  -5%
Approved Approved December 15, 2021.
$552.7 million

CHRS – Coherus BioSciences Inc.
YUSIMRY (adalimumab-aqvh)
Psoriasis

$12.59
-0.13  -1%
Approved Approved December 20, 2021.
$966.7 million

DARE – Dare Bioscience Inc.
DARE-BV1
Bacterial Vaginosis

$1.52
-0.07  -4%
Approved FDA Approval on December 7, 2021.
$116.4 million

EGRX – Eagle Pharmaceuticals Inc.
Vasopressin
Increase blood pressure in adults

$46.76
+0.37  +1%
Approved Approved December 15, 2021. Tentative approval granted due to the FDA determining that vasopressin is bioequivalent and therapeutically equivalent to Par Sterile Products' VASOSTRICT, noted December 29, 2021.
$603.9 million

GBT – Global Blood Therapeutics Inc.
OXBRYTA (Voxelotor)
Sickle cell disease - children age 4-11

$26.54
-0.25  -1%
Approved Approved December 17, 2021.
$1.7 billion

ITCI – Intra-Cellular Therapies Inc.
CAPLYTA (Lumateperone)
Bipolar depression

$42.66
+3.79  +10%
Approved Approved December 20, 2021.
$3.9 billion

RETA – Reata Pharmaceuticals Inc.
Bardoxolone methyl
Alport Syndrome

$26.18
-1.08  -4%
PDUFA PDUFA date February 25, 2022. Advisory committee meeting resulted in a 0-13 against proven demonstration of effectiveness in slowing the progression of CKD in Alport Syndrome, noted December 8, 2021.
$952.7 million

VERU – Veru Inc.
ENTADFI (tadalafil and finasteride combo)
Benign prostatic hyperplasia (BPH)

$4.90
-0.31  -6%
Approved Approved December 13, 2021.
$392.1 million