BPC October 13 update

Ardelyx ARDX -17% Type A Meeting; Rezolute RZLT -14% Offering

Price and Volume Movers

Ardelyx, Inc. (NASDAQ: ARDX) announced that it met with the FDA in a Type A meeting but did not receive clarity on what constitutes “clinical relevance of the magnitude of treatment effect.” The meeting was in regards to Ardelyx’s New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Shares closed down 17% at $1.09.

Rezolute, Inc. (NASDAQ: RZLT) announced the pricing of an underwritten public offering of its stock at $6.50 per share and pre-funded warrants. The aggregate gross proceeds from the offerings are to be approximately $55 million. Shares closed down 14% at $6.53.

Atara Biotherapeutics, Inc. (NASDAQ: ATRA) announced updated Phase 1 open-label extension (OLE) data in patients with progressive multiple sclerosis (MS) treated with ATA188. Of 18 patients, 9 achieved sustained disability improvement (SDI), and 7 sustained expanded disability status scale improvement. The median time for maintained SDI was 18 months, with a range from 0.03 to 27 months. Shares closed down 13% at $15.66.

Relay Therapeutics, Inc. (NASDAQ: RLAY) shares traded on heavy volume at over 4.7 million shares against a daily average of about 659,000. This action comes after Relay priced an underwritten public offering of 13.2 million common shares at $26.50 per share for expected gross proceeds of about $350 million. Shares closed up 18% at $32.76.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$3.02+0.52  +20.89%
ATHA
Athira Pharma Inc.
$10.76+1.13  +11.73%
CNTX
Context Therapeutics Inc.
$6.89+0.72  +11.72%
RPTX
Repare Therapeutics Inc.
$24.63+1.87  +8.22%
CABA
Cabaletta Bio Inc.
$13.98+1.03  +7.99%
KALA
Kala Pharmaceuticals Inc.
$2.05+0.15  +7.89%
CMPS
COMPASS Pathways Plc
$37.80+2.49  +7.05%
PTPI
Petros Pharmaceuticals Inc.
$1.80+0.1  +5.88%
EYEN
Eyenovia Inc.
$6.31+0.34  +5.70%
MRTX
Mirati Therapeutics Inc.
$187.21+9.91  +5.59%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.64-2.19  -57.05%
OCUL
Ocular Therapeutix Inc.
$6.95-3.88  -35.87%
AGEN
Agenus Inc.
$3.90-1.24  -24.07%
SIOX
Sio Gene Therapies Inc.
$2.03-0.33  -13.98%
STAB
Statera Biopharma Inc.
$3.33-0.54  -13.95%
RNLX
Renalytix AI plc
$24.41-2.99  -10.91%
APLT
Applied Therapeutics Inc.
$13.98-1.71  -10.87%
XFOR
X4 Pharmaceuticals Inc.
$4.43-0.52  -10.51%
GRCL
Gracell Biotechnologies Inc.
$10.50-1.22  -10.41%
GRTX
Galera Therapeutics Inc.
$1.80-0.2  -10.20%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABEO – Abeona Therapeutics Inc.
ABO-102
Sanfilippo syndrome type A (MPS IIIA)

$0.86
-0.04  -5%
Phase 1/2 Phase 1/2 updated safety data released February 12, 2021. Phase 1/2 pivotal data due in 2022.
$87.1 million

ARDX – Ardelyx Inc.
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis

$1.14
-0.06  -5%
CRL FDA issued CRL on July 29 2021. The FDA held a Type A meeting with Ardelyx, but it did not provide enough clarity on what constitutes "clinical relevance of the magnitude of treatment effect" and continues to await additional information regarding the path forward for the company's NDA, noted October 13, 2021.
$117 million

ATRA – Atara Biotherapeutics Inc.
ATA188 (EMBOLD)
Multiple sclerosis

$15.84
+0.03  +0%
Phase 1/2 Phase 1 data presented at ECTRIMS 2021 indicated that the dose continues to be well-tolerated with no new safety findings in this patient population. Also, patients may achieve sustained disability improvement (SDI), with most driven by EDSS, at a higher rate and longer duration than expected based on the natural history of progressive MS, with MTR analysis demonstrating that structural changes suggestive of remyelination may be driving sustained EDSS improvements, noted October 13, 2021. Phase 2 interim analysis 1H 2022.
$1.3 billion

AVXL – Anavex Life Sciences Corp.
ANAVEX2-73-AD-004
Mild to moderate Alzheimer’s disease

$17.72
-0.26  -1%
Phase 2/3 Phase 2b/3 upon review of safety interim data, the DSMB recommendation is to continue the studies without modification. Topline data due 2H 2022.
$1.3 billion

BIIB – Biogen Inc.
Natalizumab - NOVA
Multiple sclerosis (MS)

$264.77
-5.44  -2%
Phase 3 Phase 3b data displayed that the proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0 percent for Q6W and 67.4 percent for Q4W. The proportion of patients free of disability worsening was 90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm. Time to first relapse with the proportion who were relapse-free at 72 weeks at 96.9 percent for Q6W and 97.6 percent for Q4W, noted October 13, 2021
$38.9 billion

CWBR – CohBar Inc.
CB4211
Nonalcoholic Fatty Liver Disease / Obesity / Nonalcoholic steatohepatitis

$0.90
-0.03  -4%
Phase 1b Phase 1b top-line data met primary endpoint - August 10, 2021. Phase 1a/1b results to be presented in a poster at the Liver Meeting November 12-15, 2021.
$58.3 million

IBRX – ImmunityBio Inc.
t-haNK and Anktiva (N-803) - QUILT-88
Pancreatic cancer

$8.26
-0.19  -2%
Phase 2 Phase 2 interim data released January 14, 2021. Phase 2 enrollment in cohort C to increase. Phase 2 data showed 90% of cohort C (43/48) remained on therapy, and evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates, noted October 13, 2021. Phase 2 mature data expected in 1Q 2022.
$3.2 billion

KYMR – Kymera Therapeutics Inc.
KT-474
Hidradenitis suppurativa / atopic dermatitis

$55.99
+1.22  +2%
Phase 1 Phase 1 healthy volunteers completed dose escalation, noted October 13, 2021. PK and PD from the Single Ascending Dose (SAD) data to be presented at the 4th Annual Targeted Protein Degradation Summit from October 26 - 29, 2021. Phase 1 MAD data due 4Q 2021 with AD and HS patient cohort data due 1H 2022.
$2.9 billion

LLY – Eli Lilly and Company
VERZENIO (Abemaciclib)
HR+ / HER2- breast cancer

$242.81
+1.64  +1%
Approved Approved October 13, 2021.
$232.3 billion

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab) + chemo with or without bevacizumab
Cervical Cancer

$80.90
-0.27  0%
Approved Approved October 13, 2021.
$204.8 billion

NRBO – NeuroBo Pharmaceuticals Inc.
ANA-001
COVID-19

$1.87
-0.02  -1%
Phase 2/3 Phase 2/3 safety data reviewed by DMC, the committee has recommended the continuation of the trial without modification. Phase 3 initiation and Phase 2 portion of the trial expected to be completed 4Q 2021.
$49.7 million

VACC – Vaccitech plc
VTP-300 (HBV002)
Hepatitis B

$14.41
-0.34  -2%
Phase 1/2 Phase 1b/2a data to be presented at the Liver Meeting November 12-15, 2021. Phase 1b/2a interim efficacy review 1Q 2022.
$494.7 million

VBIV – VBI Vaccines Inc.
Sci-B-Vac - CONSTANT
Hepatitis B vaccine

$3.06
+0.01  +0%
Phase 3 Phase 3 pivotal study results indicated that primary endpoint of lot-to-lot manufacturing consistency was achieved. SPR after two doses, at Day 168, was 90.4% for VBI's 3-antigen vaccine candidates compared to 51.6% for Engerix-B, increasing to 99.3% and 94.8%, respectively, after the third dose. Mean GMC of anti-HBs titers was more than 7.5x higher after two doses. The safety and tolerability seen in this study support the safety profile of the vaccine candidate, noted October 13, 2021.
$783.4 million

VERA – Vera Therapeutics Inc.
Atacicept - JANUS
IgA nephropathy (IgAN)

$17.05
+0.50  +3%
Phase 2a Phase 2a data to be presented the American Society of Nephrology Kidney Week November 4, 2021.
$362.8 million

VRNA – Verona Pharma plc
Ensifentrine (RPL554) - Metered Dose Inhaler
Chronic obstructive pulmonary disease (COPD)

$5.01
-0.04  -1%
Phase 2 Phase 2 MDI data met primary endpoint - February 2, 2021. Phase 2 part B data noted when administered by hand-held pMDI over one week treatment provided clinically meaningful, statistically significant and dose-dependent bronchodilation, noted October 13, 2021.
$300.8 million